Device for intermittently obstructing a gastric opening and method of use

ABSTRACT

The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member includes an apron member surrounding a first occluding member, which is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device of the present invention is arranged transluminally, with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve. In certain embodiments, a reservoir may be included for releasing a substance of interest, for example for releasing insulin from a reservoir disposed in the distal member. Sensors, actuators, and data transmission devices may also be included.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Prov. Pat. App.60/970,619 filed Sep. 7, 2007, which is incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

The present invention relates to a gastro-intestinal device for treatingobesity and other medical conditions. More particularly, the presentinvention relates to a device that is positioned transluminally in apatient's gastro-intestinal tract to intermittently obstruct or reducethe flow of gastric contents.

BACKGROUND OF THE INVENTION

Obesity is a condition of epidemic proportions in the United States.Recent government studies have indicated that up to 40% of Americans areobese and that, among those, almost 20% are morbidly obese. Obesity isnot the problem in and of itself, but is the source of multiplepathological conditions, including cardiovascular disease, heartdisease, stroke, diabetes, and obstructive sleep apnea. Recent studieshave indicated that obesity can reduce a person's lifespan by an averageof three years in adults and twenty years in children.

Many attempts have been made in the prior art to provide medications,devices, and surgical procedures for the treatment of obesity, all ofwhich either have serious side effects or are basically ineffective. Forexample, various diets, supplements and pharmaceuticals have beendeveloped and marketed, but none have shown any significant benefits todate in the treatment of obesity with the exception of somepharmaceuticals, which have unfortunately been found to cause a numberof serious, life-threatening medical conditions. To date, there are nocommercially available supplements or drugs that have been proven to beeffective in promoting significant weight loss and at the same time thatare free from serious collateral side effects.

Recognizing that no cure has been developed to date that is botheffective and safe, the medical industry has introduced more extremeprocedures, an example of which is the Roux-En-Y gastric bypass. Thisextensive and invasive surgery is highly effective but is alsopotentially lethal, with a 1-2% mortality rate, a six month recoveryperiod; and a cost of tens of thousands of dollars, yet it is becomingincreasingly popular because other available treatments do not producethe desired results. Gastric reduction, or simply removing a largesegment of the stomach, is another procedure that is similar to gastricbypass and that, like gastric bypass, has also been associated withpotentially lethal complications. Data from recent studies haveindicated that even in the lowest risk groups, obesity surgery causes anaverage one-year mortality rate of nearly 5%.

In another attempt to treat obesity, devices have also been developed inthe prior art that are aimed at providing a sense of fullness to apatient, so to cause the patient to reduce food intake. Such devices maybe configured as stents that support the stomach or the pyloric valve toor that may be configured as permanent occluders. Unfortunately, thesedevices are implanted in the patient on an essentially permanent basisand typically include complex mechanical or electrical features that maystop working properly over time or that may require maintenance fromtime to time. Examples of such devices in the prior art can be found inU.S. Pat. Nos. 5,509,888; 6,067,991; 6,527,701; 6,689,046; 7,011,621;7,737,344; 7,120,498; 7,122,058 and 7,167,750, and in U.S. PatentApplication Publications Nos. 2004/0172142; 2005/0273060; 2007/0016262;2007/0027548; and 2007/0083224.

Evidence has been developed showing that benefits can be derived fromreducing gastroduodenal flow. In unpublished, but recently presenteddata at the American Society for Bariatric Surgery conference of June2003, stimulation of the gastric vagus nerve with subsequent reductionin gastric motility resulted in a loss of over 20% of excess weight overa nine month period. Furthermore, there is data suggesting that gastricvagotomy is also effective in the treatment of obesity trough a similarmechanism. Unfortunately, these therapies require highly invasive,sometimes irreversible, surgical procedures, making them undesirable fora large segment of the obese population.

BRIEF SUMMARY OF THE INVENTION

It is an object of the present invention to provide a device for thetreatment of obesity and related conditions that intermittentlyobstructs a transluminal passage, such as a gastric opening.

It is also an object of the present invention to provide a device forthe treatment of obesity and related conditions that is well toleratedby the stomach and in general, by the gastro-intestinal tact.

It is a further object of the present invention to provide a device forthe treatment of obesity and related conditions that can be implantedand removed with medical procedures that are safe and relatively simpleto perform.

Briefly, the device of the present invention operates as a transluminaldevice that obstructs the pylorus or other organ on an intermittentbasis and that causes a reduced flow of gastric contents into theintestinal tract. The device of the present invention may just occupyspace in the stomach and occlude the pyloric valve from time to time, oralso may partially obstruct the duodenum or the small intestine,reducing overall gastrointestinal transit. The intermittent blockage ofthe gastrointestinal tract results in weight loss and also in anincreased or sustained feeling of fullness by the patient.

The device of the present invention can be placed and removed withsimple endoscopic procedures and is completely reversible. Inparticular, the device of the present invention can be inserted andremoved orally, nasally or transcutaneously and, in certain embodiments,can be triggered externally or can be caused to expand or canself-expand once in the gastrointestinal space.

In one embodiment, a device according to the present invention includesa proximal member oriented in the direction of the stomach afterimplantation and a distal member oriented in the direction of theduodenum after implantation that are connected by a tether.

The proximal member is composed of a first occluding member surroundedby an apron member. The first occluding member is formable from anelongated, narrower configuration to a contracted, wider configuration,while the apron member has an essentially cylindrical portion thatsurrounds the first occluding member and an essentially conical portionthat connects the apron member to the tether, providing the apron memberwith a funnel-like shape. In one embodiment, the cylindrical portion isspaced from the first occluding member by an interstice, and thecylindrical and conical portions may have different wall thickness.

The first occluding member may be formable from the narrowerconfiguration to the wider configuration by injecting a substance withinthe first occluding member, or may have a solid structure that can becompressed to assume an expanded shape, in order to transition form theelongated configuration to the wider configuration.

In one embodiment, the elongated configuration exhibits a helicalcontour with a plurality of turns, and the wider configuration is formedfrom the helical configuration by nesting the turns one adjacent to theother to provide a bulbous body. The wider configuration is then lockedin place by engaging a connecting member at the proximal end of thefirst occluding member with a mating cavity at the distal end of thefirst occluding member. This may be achieved by having a clinician pullon a string coupled to the connecting member in the direction of themating cavity.

In one embodiment, such coupling string extends outside of the devicealong its entire length and then enters a lumen running from the firstoccluding member to the second occluding members through the tether.When entering the first occluding member, the string is looped throughthe connecting member and is removable from the device after theconnecting member has engaged the matching cavity. The proximal end ofthe first occluding member may be reinforced to increase its resistanceto tear during the compression of the first occluding member byincluding a reinforcing material in at least part of the structure ofthe proximal end.

The transformation process from the elongated configuration to the widerconfiguration is reversible, so that the device can be implanted in thestomach in the elongated configuration, reside in the stomach and/orgastro-intestinal tract in the wider configuration, and be removed fromthe stomach through the esophagus in the elongated configuration. In oneembodiment, the wider configuration reverses to the elongatedconfiguration by severing the connecting member from the proximal end,for example, by having a clinician cut a string coupling the connectingmember to the proximal end or to a release member in the proximal end.

A device according to the present material is manufactured from amaterial that is biocompatible, that is able to withstand thegastrointestinal environment, and that prevents or anyways minimizesabrasion of the walls of the stomach and duodenum, particularly of thepyloric valve. In one embodiment, the device is manufactured from aresilient plastic material, for example, from a silicone material, andthe apron member may be constructed to be flexible enough to reversefrom a position surrounding a portion of the tether to a positionsurrounding the first occluding member, in order to facilitate insertionin the stomach according to one method of use.

The second occluding member also may have a bulbous shape, like a pod,and include an insert having a heavier weight than the remainder of thesecond occluding member, so to facilitate disposition and retention inthe duodenum.

The device of the present invention is suited not only for the treatmentof obesity, but also for treating other ailments, such as improperglucose tolerance in a diabetic or prediabetic subject and theprogression of diabetes itself by inhibiting fasting insulin secretionor glucose-stimulated insulin secretion. The resent device is alsosuited for treating other ailments deriving from obesity, includinghyperphagia, dyslipidemia, Prader Willi syndrome, Froelich's syndrome,Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome,Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, andIV.

The device of the present invention may also include sensors ortransmitters to provide feedback and other data to an intra-corporeal orextra-corporeal processor, or may carry one or more compounds stored ina reservoir within the device or coated on the device. In oneembodiment, insulin is released into the gastro-intestinal tract bydisposing an insulin reservoir in the distal member of the device. Sucha release of insulin may be controlled by the size of the orificebetween the reservoir and the outer environment, or by a time-controlledactuator, or by an actuator controlled by one or more sensors, forexample in response to detection of sugar in the gastro-intestinaltract.

Other embodiments of the present invention, methods of use of a devicemanufactured according to the present invention, and methods oftreatment of a variety of ailments using the device of the presentinvention are discussed in detail in the following sections.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The drawings constitute a part of this specification and includeexemplary embodiments of the invention, which may be embodied in variousforms. It is to be understood that in some instances various aspects ofthe invention may be shown exaggerated or enlarged to facilitate anunderstanding of the invention.

FIG. 1A illustrates a perspective view of a first embodiment of theinvention in the elongated, narrower configuration.

FIG. 1B illustrates a perspective view of the embodiment of FIG. 1A inthe contracted, wider configuration.

FIGS. 1C-1E illustrate respectively a cross-sectional view of theproximal member of the embodiment of FIG. 1B, to which a protective caphas been added (FIG. 1C); a side view of the embodiment of FIG. 1B withthe protective cap (FIG. 1D); and a cross-sectional view of theembodiment of FIG. 1D (FIG. 1E).

FIG. 1F illustrates a cross-sectional side view of one example of adevice having a sensor incorporated within for confirming or detectingwhether the occluding member has been locked into its deploymentconfiguration.

FIGS. 2A-2C illustrate respectively a cross-sectional side view and topand bottom end views of another embodiment.

FIGS. 2D-2E illustrate respective side and cross-sectional perspectiveviews of the embodiment of FIGS. 2A-2C.

FIGS. 3A-3B illustrate side and cross-sectional side views,respectively, of yet another embodiment where an occluding member isseparately fabricated and removably attachable within an apron member.

FIG. 3C illustrates a cross-sectional side view of an assembled devicefrom FIGS. 3A and 3B.

FIG. 4 is a graph depicting the efficacy of the first embodiment of theinvention in different variants.

FIG. 5 is a partial cross-sectional side view of the proximal portion ofa second embodiment of the invention.

FIG. 6A is a partial cross-sectional side view of a third embodiment ofthe invention, while FIG. 6B is a side view of a variant of theembodiment of FIG. 6A.

FIG. 7 is a partial cross-sectional side view of the embodiment of FIG.6A in partially deployed state.

FIG. 8 is a partial cross-sectional side view of the embodiment of FIG.6A in the elongated, narrower configuration.

FIG. 9 is a partial cross-sectional side view of a fourth embodiment ofthe invention.

FIG. 10A is a partial cross-sectional side view of a detail of a fifthembodiment of the invention, while FIG. 10B is a perspective view of thefirst occluding member of the embodiment of FIG. 10A.

FIG. 11A is a cross-sectional side view of a detail of a sixthembodiment of the invention, while FIG. 11B is a perspective view of thefirst occluding member of the embodiment of FIG. 11A.

FIGS. 12A-12B are cross-sectional side views of a seventh embodiment ofthe invention, in a deployed state (FIG. 12A) and in a partiallydeployed state (FIG. 12B).

FIGS. 13A-13B are partial cross-sectional side views of an eighthembodiment of the invention.

FIG. 14A-14B are cross-sectional side views of a ninth embodiment of theinvention, in the deployed state (FIG. 14A) and undeployed state (FIG.14B), while FIG. 14C illustrates a detailed view of the connecting andretaining members in the embodiment of FIGS. 14A-14B.

FIG. 15A is a further cross-sectional view of the embodiment of FIG.14A, while FIGS. 15B-15D illustrate detailed views if the coupling ofthe connecting member with the mating cavity.

FIG. 16A is a cross-sectional side view of a tenth embodiment of theinvention, while FIG. 16B is a detailed view of the connecting elementof the embodiment of FIG. 16B.

FIG. 17 is a cross-sectional side view of the embodiment of FIG. 16A inthe undeployed state.

FIG. 18 is a cross-sectional side view if a variant of the embodiment ofFIG. 16A.

FIG. 19 is a cross-sectional view of a twelfth embodiment of theinvention.

FIGS. 20A-20C; 21A-21B; and 22A-22C are side views of differentembodiments of the first occluding member in the embodiment of FIG. 19and of their mode of deployment.

FIGS. 23A-23C illustrate a device introduced in the stomach or otherpart of the gastro-intestinal tract in an elongated configuration (FIG.23A), expanded to an intermediate configuration (FIG. 23B) and to afinal configuration (FIG. 23C) by injecting a foam with an appropriatecatheter.

FIGS. 24A-24C illustrate a process similar to that of FIGS. 23A-23C,except that a substance such as water, a reagent and/or a catalyst isinjected through the catheter.

FIGS. 25A-25C illustrate schematically a mode of placement of thedevices of FIGS. 23A-23C and 24A-24C through a catheter introducedthrough the esophagus (FIG. 25A), then used for infusing foam or agrowth substance (FIG. 25B) and eventually causing the device to becomefully inserted (FIG. 25C). Conversely,

FIGS. 26A-26D illustrate the removal of such a device by showing thedevice in its placed state (FIG. 26A), the attachment of a deviceextractor (FIG. 26B), the activation of predetermined failure points(FIG. 26C), and the extraction of the device (FIG. 26D).

FIGS. 27A-27C illustrate other embodiments, in which multiple distalbulbs (FIG. 27A) or a larger distal bulb (FIG. 27B) may be present toslow transit of food in the gastrointestinal tract, or in which nodistal bulb may be present and the device can act as a space filler(FIG. 27C).

FIGS. 28A-28C illustrate a mode by showing insertion (FIG. 28A),inflation of the bulbs (FIG. 28B), and the intestinal migration of thedistal bulb (FIG. 28C). FIG. 28D illustrates the obesity treatmentenhanced by adding gastric fillers in the stomach.

FIG. 29A illustrates a cross-sectional side view of an embodiment wherean occluding member may be folded within a receiving channel such that adistal protrusion is mated in a secured manner within a mating cavity.

FIG. 29B illustrates a cross-sectional side view of another embodimentwhere the distal protrusion is configured in a shape which resists orinhibits withdrawal from the mating cavity.

FIG. 29C illustrates cross-sectional side views of yet anotherembodiment where the device may be collapsed by actuation of atensioning wire or string.

FIGS. 30A and 30B illustrate cross-sectional end views of alternativevariations of the device of FIG. 29C where respective mating surfaces ofthe collapsed device may incorporate adhesion or interlocking surfacefeatures for securing the device in its collapsed configuration.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Detailed descriptions of embodiments of the invention are providedherein. It is to be understood, however, that the present invention maybe embodied in various forms. Therefore, the specific details disclosedherein are not to be interpreted as limiting, but rather as arepresentative basis for teaching one skilled in the art how to employthe present invention in virtually any detailed system, structure, ormanner.

FIG. 1A depicts a first embodiment of the invention, which is configuredfor insertion into a patient's organ, typically the stomach. Device 30includes a proximal member 32 and a distal member 34, which areconnected one to the other by a tether 36. The relative sizes ofproximal member 32 and of distal member 24 are such that, afterinsertion into the stomach of a patient, the natural contractions of thestomach and, in general, the movements of the patient induce distalmember 34 to enter the pyloric part of the gastrointestinal tract andthe duodenum, while proximal member 32 is retained in the stomach andcannot move beyond the pyloric valve because its diameter is larger thanthe pyloric valve opening.

More particularly, proximal member 32 includes a first occluding member38, disposed in a central position within an apron member 40. Firstoccluding member 38 may be formed from an elongated, narrowerconfiguration as shown in FIG. 1A to a contracted, wider configurationas shown in FIG. 1B. In the embodiment illustrated in FIG. 1A, firstoccluding member 38 has a helical design with a plurality of turns 42,which are configured to nest one adjacent to the other to assume thecompact, bulbous shape illustrated in FIG. 1B.

Apron member 40 wraps around first occluding member 38, providingproximal member 32 with a enlarged diameter and preventing the passageof proximal member 32 through the pyloric valve. In one variant of thepresent embodiment, apron member 40 includes an essentially cylindricalproximal portion 44 connected to an essentially conical distal portion46 that extends from tether 36 to proximal portion 44. Thisconfiguration of apron member 40 is designed to provide an intermittentplugging effect on the pyloric valve and to avoid or anyways minimizeabrasive contact with the wall of the pyloric valve during such pluggingeffect, so to prevent or minimize patient discomfort and irritations oreven lacerations to the mucosa of the stomach and, in general, to thegastro-intestinal tract.

Distal portion 46 may have a smaller wall thickness than proximalportion 44, both providing a gentler, suppler contact with the pyloricvalve, and also facilitating the reversal of apron member 44 duringinsertion into a patient's stomach from a position substantially alignedwith tether 36 to the position that wraps around first occluding member38, as explained in greater detail below.

In different variants of the present embodiment, apron member 40 mayextend proximally for various lengths, surrounding first occludingmember 38 partially or completely. Further, in different variants of thepresent embodiment, apron member 40 may be spaced from first occludingmember 38 at various distances to create an interstice 48 of differentamplitudes between first occluding member 38 and apron member 40.

Second occluding member 34 may exhibit a variety of contours and ingeneral, is shaped to facilitate its transition out of the stomach andinto the duodenum, and to avoid or minimize abrasive contact with thewalls of the stomach and of the pylorus. In one embodiment, secondoccluding member 34 has a bulbous shape, essentially formed by tworounded, frusto-conical portions 50 connected at their wider bases.

Device 30 may be manufactured from a variety of materials, for example,from a resilient plastic such as a silicone or urethane plastic, whichmay be reinforced in selected portions. In general, the selectedmaterial should be biocompatible, resistant to the stomach environment,for example to stomach acids, and soft to the contact with the stomachand duodenal walls. The desired material should also provide device 30with the desired shape while retaining sufficient flexibility for theinsertion process in the stomach, for later reverting to the desiredposition within the gastro-intestinal tract, and for adapting to thevarious movements of the stomach and, in general, of the body of thepatient.

Inserts may be integrally included within the body of device 30 toincrease certain mechanical properties in certain areas. For example, aninsert (such as a metallic cylinder) may be embedded within secondoccluding member 34 to increase weight and to facilitate retention bygravity within the pylorus. Another insert (such as a fabric piece) mayalso be embedded in proximal end 52 of first occluding member 38,increasing resistance to tear when proximal end 52 is pulled outwards toextend first occluding member to the configuration of FIG. 1, or inwardsto stabilize first occluding member in its contracted, widerconfiguration, as explained in greater detail below.

The insertion of device 30 in a patient's stomach will now be describedwith reference to FIG. 1C. It should be noted that FIG. 1C illustrates,among other things, one variant of the embodiment of FIGS. 1A and 1B, inwhich a stabilizing cap 54 is added to maintain first occluding member38 in the contracted, wider configuration, and also to increase bulk andto prevent the introduction of food or other gastric products withininterstice 48.

In one method of use, device 30 is introduced in a patient's stomach inthe elongated, narrower configuration of FIG. 1A, with apron member 40oriented in the opposite direction to that shown in FIG. 1A, that is, tocover tether 36 while the free end of distal portion 46 is orientedproximally, in the direction of second occluding member 34. When in thisconfiguration, device 30 is disposed within a tube (not shown) and iscaused to exit the tube with proximal end 52 first, followed by the restof the device. When device 30 has partially exited the tube (oralternatively, the tube has been retracted from device 30) so to leaveapron member 40 outside of the tube, device 30 is pulled inside thetube, but because apron member 40 surrounds and wraps around the end ofthe tube, such a pulling of device 30 inwards into the tube, causingapron member 40 to flip over and change orientation, so to wrap aroundfirst occluding member 38. After such a flipping around of apron member40 has been achieved, device 30 is completely ejected from the tube andbecomes disposed in the stomach. Alternatively, device 30 may beintroduced in a patient's stomach with apron member 40 already orientedproximally, making unnecessary the previously described flippingoperation.

While the configuration of first occluding member 38 makes it recoil andassume the contracted configuration, similar to that shown in FIG. 1B,the fully contracted, wider configuration of first occluding member 38is achieved and maintained as follows. A connecting member 56 is coupled(for example, by a first string) to a release member 58. A second string60 is looped around device 30, running outside and along device 30starting from a first free end, and then extending within connectingmember 56 through lumen 66, and then (within a lumen or a tube) withinturns 42, successively entering a lumen 62 in tether 36 and secondoccluding member 34 (see also FIGS. 1D and 1E), and eventually exitingdevice 30 with a second free end.

After device 30 has been introduced in the stomach, a clinician can holdboth ends of second string 60 and, by pulling on second string 60 whiledevice 30 is constrained within the stomach, the clinician causesconnecting member 56 to travel in the direction of mating cavity 64,shaped so to constrain connecting member 56 (for example, byinterference fit) and to prevent connecting member 56 from beingreleased. Therefore, first occluding member 38 is locked into itscontracted, wider condition on a permanent basis.

After device 30 has been shaped as described, second string 60 isremoved by pulling on one free end and by having second string 60 slidethrough the lumens within device 30, eventually exiting device 30entirely. Device 30 is now free to move freely within the stomach, andthe natural contractions of the stomach, in addition to any othermovements of the patient's body, cause distal member 34 to move into thepylorus, while the size of proximal member 32 prevents it from movinginto the pylorus and forces it to reside in the stomach. Therefore,distal member 34 will eventually be disposed in the pylorus, and anyinserts of a heavier weight will facilitate retention of distal member34 in the pylorus, while proximal member 32 will act as an intermittentplug against the pyloric valve, because stomach contractions and otherbody movements will cause proximal member 32 to move towards and awayfrom the pyloric valve, acting as an intermittent plug and allowing thepassage of some food from time to time.

Another embodiment is illustrated in the cross-sectional side view ofFIG. 2A and the top and bottom end views, respectively, of FIGS. 2B and2C. In this embodiment, device 31 may also include a distal member 33connected or attached via tether 35 to proximal member 37. As describedabove, proximal member 37 may comprise an apron member 39 which definesa curved or otherwise arcuate surface which tapers radially from tether35 at a distal portion 41 (which typically contacts the stomach interiorsurface when in use) to a curved proximal portion 43 which has arelatively larger diameter and which may define a circumferential lip oredge 53 which is atraumatic to surrounding tissue. Apron member 39 maydefine a channel or interstice 45 within which first occluding member 47may reside when occluding member 47 is in its contracted deploymentconfiguration, as illustrated. With occluding member 47 contracted,apron member 47 may be configured to entirely or at least partiallyencircle or enclose occluding member 47, as illustrated in FIGS. 2D and2E which respectively show side and cross-sectional perspective views.Moreover, interstice 47 may be left open when in use in the patient bodyor an additional cap member or covering may be optionally attached tofully enclose apron member 39 and occluding member 47 within, if sodesired.

Occluding member 47 may be formed into a coiled or wound structurehaving a plurality of turns and a distal end which is attached, coupled,or otherwise formed integrally with device 31 at connecting portion 49.Because of its coiled or wound helical structure, occluding member 47may be extended in a low-profile configuration, as above, for deliveryinto the patient body and then allowed to compress or contract into itscoiled structure which forms a diameter or cross-sectional area which isrelatively larger than a diameter of distal member 33 to inhibit orprevent the passage of proximal member 37 through the pylorus when inuse. As in the aforementioned embodiment, occluding member 47 may bebiased or configured to self-contract. Alternatively, a string member orother locking mechanism, as described herein, may be actuated tocompress and/or lock the structure such that the expanded configurationis maintained and prevented from releasing and reconfiguring back intoits low-profile configuration. Distal member 33 may further define alumen or channel 51 to facilitate the placement and/or positioning ofdevice 31 within the patient body.

In yet another embodiment, the occluding member may be fabricated as aseparate component and attached or coupled within the apron member at alater time rather than forming the occluding member as a continuousintegral component. This particular embodiment allows for the size andshape of the occluding member to be varied and altered according to anypatient-specific parameters and attached within a common apron member.As shown in the side view of FIG. 3A and the cross-sectional side viewof FIG. 3B, occluding member 61 may be formed as a coiled or woundhelical structure which defines a channel 65 and a receiving portion 63when in its collapsed deployed configuration. As previously described,occluding member 61 may be advanced into the patient body in an extendedlow-profile configuration and then collapsed into its expanded andoptionally locked configuration, as shown, either via actuation or byallowing for self-reconfiguration.

Because the coiled portion of occluding member 61 may form a receivingportion 63 in its collapsed configuration, portion 63 may be coupled toa complementary securement mechanism positioned within apron member 37.In this example, the securement mechanism may be comprised of aconnecting portion 55 which extends distally within apron member 37.Connecting portion 55 may have a securement member 57, such as a taperedportion, and a stop member 59 which each limit the movement of portion63 relative to connecting portion 55.

As illustrated in the cross-sectional side view of FIG. 3C, occludingmember 61 is shown in its collapsed and locked configuration whilesecured within interstice 45 and encircled by apron member 37. As shown,securement member 57 may be advanced at least partially within channel65 formed by the wound occluding member 61 to prevent the relativemovement or release of occluding member 61 from connecting portion 55.The connecting portion 55 is illustrated as an example and is notintended to be limiting. Other known securement mechanisms may beutilized as practicable.

In these and other embodiments described herein, because the device maybe introduced into the patient body in a minimally invasive manner,e.g., per-orally and through the esophagus into the patient's stomach,the device may be delivered in its low-profile configuration, e.g.,where the occluding member is in its uncoiled or unwound elongateconfiguration. Alternatively, the device may be delivered in a partiallylocked configuration. Once within the stomach, for instance, the devicemay be coiled or wound into its deployment configuration and theoccluding member may be affirmatively locked into position relative tothe device such that its enlarged profile inhibits or prevents thepassage of the device through the pylorus. In ensuring that theoccluding member is locked into its expanded configuration, variousmechanisms may be utilized to confirm its securement.

One example includes having the string for locking the occluding memberbe color-coded such that one portion of the string is of a differentcolor, e.g., red, than the remainder of the string. As the string istensioned to lock the occluding member, once the color-coded portion isexposed from the device the user may visually confirm that the occludingmember is locked into its deployment configuration. Alternatively, theamount of tension required to lock the device may be calibrated toincrease to a preset level once the device is locked such that the usermay confirm by tactile feedback that the device is indeed locked.

Other alternative mechanisms for locking confirmation or detection ofthe occluding device may additionally include sensors incorporatedwithin the device. An example is illustrated in the cross-sectional sideview of FIG. 1F, which shows sensor 67 positioned within the device.Sensor 67 may incorporate any number of detection modalities, e.g.,acoustic, ultrasonic, electrical, electromagnetic, optical (forinstance, detecting changes in color, wavelength, frequency, etc.),chemical, etc. which may sense changes in the occluding member from itscoiled deployment configuration or changes in the string tension,connecting member 56, or release member 58.

Based on the foregoing, device 30 (and variations thereof) assists inthe treatment of obesity by limiting the passage of food from thestomach into the intestine, and at the same time by reducing the intakeof food by the patient due to the sense of fullness generated by theretention of food in the stomach for a longer time and also by to thepresence of device 30 in the stomach.

Experiments performed with the above-described embodiments indicate a“dose-response” relationship between the thickness of the wall of distalportion 46 and weight loss of the patient. For example, a series ofexperiments performed on dogs and summarized in FIG. 4 indicate that thegreater the thickness of the wall of distal portion 46, the greater therate of weight loss.

In one version of the present embodiment, apron member 40 has a totallength of 38 mm, with the proximal (cylindrical) portion having a lengthof 15 mm and an outer diameter of 53 mm, and the distal (conical)portion having a length of 23 mm. The first occluding member 38 has, inits contracted configuration, both a length and a width of 35 mm, whiledistal member 34 has a length of 25 mm and a diameter of 15 mm, withdevice 30 having a total length of 142 mm. In this version, the wall ofthe distal portion 46 of apron member 40 may have a thickness of 1.3 mmfor a maximum rate of weight loss, of 0.9 mm for a medium rate of weightloss, and of 0.5 mm for a lower rate of weight loss.

After device 30 has achieved its desired result, or when it becomesdesirable to remove device 30 for any reasons, different removal optionsare available to a clinician. One removal option is surgical removal,for example, laparoscopic surgical removal. Another option involvesremoval through the esophagus and the throat by causing first occludingmember 38 to reverse from its contracted, wider configuration to itselongated, narrower configuration. To achieve such change ofconfiguration, proximal end 52 of first occluding member 38 must becomedisengaged from connecting member 56, which is also engaged in cavity64. As previously described, connecting member 56 is coupled (forexample, with the first string) to release member 58, making it possibleto disengage proximal end 52 from connecting member 56 by severing thecoupling (for example, the first string) between connecting member 56and release member 58. This can be achieved through a procedureperformed by introducing an appropriate surgical catheter (as known to aperson skilled in the art) in the stomach of the patient through theesophagus, with the assistance of an endoscope, by severing the couplingbetween connecting member 56 and release member 58, and by successivelyremoving device 30 through the esophagus.

While the present embodiment has been described in relation to obesitytreatments, it must be noted that treatments of other ailments throughdevice 30 are also possible. Examples of such treatments includetreatments to restore normal glucose tolerance to a diabetic orprediabetic subject, or to delay or prevent the progression of diabetesin a subject, by inhibiting fasting insulin secretion orglucose-stimulated insulin secretion. Other examples of such treatmentsinclude the treatments of patients suffering from one or more diseasescharacterized by obesity including hyperphagia, dyslipidemia, PraderWilli syndrome, Froelich's syndrome, Cohen syndrome, Summit syndrome,Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, andhyperlipoproteinemia, types I, II, III, and IV.

In different variants of the present embodiment, various ancillarycomponents may be included, such as sensors, miniature motors, orreservoirs. In one variant, a sensor may be placed in line with thelocking string to provide feedback information about the unexpectedunlocking of the first occluding member from its contractedconfiguration, indicating a failure of the locking mechanism. In anothervariant, a miniature eccentric motor may be included that generates avibrating sensation, for example, when a patient ingests an excessiveamount of food and food in excess of a predetermined threshold hasaccumulated towards the pyloric valve. In still another variant, areservoir containing a therapeutic substance may be included thatreleases that substance over time, or a reservoir of a mildly irritatingsubstance, that may be temporarily opened for release into the stomachwhen a sensor perceives the ingestion of an undesired substance, such assugar, so to generate an unpleasant reaction in the patient and breakthe habit of ingesting the undesired substance. The motor or thereservoir may be refilled with power, and/or the reservoir may berefilled with the desired substance, through a catheter introduced inthe esophagus and into the stomach or in the case of the motor, throughtelemetric energy transmission. Communication devices, data receivers,data storage modules, microprocessors and rechargeable power sourcesalso may be included in device 30. A therapeutic substance may also beimpregnated into the walls of device 30 to be eluted over time.

Another embodiment of the present invention is depicted in FIG. 5. Thebasic components of device 68 include a proximal member 70, a tether 72and a distal member (not shown) at the end of tether 72 opposite toproximal member 70. Parts of this embodiment and of the embodimentsdescribed hereinafter are common with the previously describedembodiments, and will not be described again here for the sake ofbrevity.

Proximal member 70 includes apron member 74, which surrounds firstoccluding member 76 and which is composed of a proximal, cylindricallyshaped portion 80 and of a distal, conically-shaped portion 78 thatconnects proximal portion 80 to tether 72. First occluding member 76includes a support member that extends from the tip of distal portion 78(which corresponds to the proximal end of tether 72) into the innerportion of apron member 74, and a cup-shaped member 84 that is connectedto support member 82 approximately midway and that has a concavityfacing proximally, with cup-shaped member 84 being joined to supportmember 82 by first joint 86. In turn, support member 82 is joined to thedistal end of distal portion 78 (which corresponds to the proximal endof tether 72) by second joint 88.

FIG. 5 illustrates the elongated, narrower configuration of device 68prior to introduction in the stomach or other organ of a patient. Inthis elongated, narrower configuration, device 68 has apron member 74oriented distally (towards the second occluding member), which requiresthat apron member 74 be reversed to change orientation and to becomedirected proximally, as shown in FIG. 5 and as described in relation toembodiment 30. Alternatively, apron member 74 may be oriented proximallyeven during introduction into the stomach of the patient.

After introduction in the stomach, first occluding member 76 is causedto assume a contracted, wider configuration through the use of a string,as described in relation to embodiment 30, that runs outside of device68 then through first ring 90 on an edge of cup-shaped member 84 andfurther through second ring 92 at a proximal extremity of support member82, and still further through a lumen within tether 72 and within thesecond occluding member. By pulling on the free ends of that string,support member 82 is caused to arch in the direction of second joint 88,acquiring and essentially closed shape, and cup-shaped member 84 iscaused to flip around, reversing orientation and overlaying theessentially closed shape of support member 82.

Therefore, first occluding member 76 is caused to acquire a convex,layered structure, with the cusp oriented proximally. As in embodiment30, second ring 92 or a connecting member are caused to engage a cavityor other structure in the area of second joint 88, becoming pennanentlyengaged. Also as in embodiment 30, removal of device 68 from the stomachmay be achieved through surgical intervention, or alternatively throughthe esophagus by causing device 68 to revert to the narrower, elongatedconfiguration by severing a string or other retainer that connects theconnecting member to a release member.

A third embodiment of the invention is depicted in FIGS. 6A-6B, FIG. 7and FIG. 8. Device 94 includes, as in the previous embodiments, aproximal member 96 and a distal member 98 connected by a tether 100. Indevice 94, first occluding member 102 includes a plurality of struts104, that may be formed as individual struts connecting the proximal anddistal ends of first occluding member 102, in the fashion of the ribs ofa cage, or that may be formed as sheets extending from the longitudinalaxis of first occluding member 102, in the fashion of pages of a book.In one version of device 94, struts 104 are manufactured from a siliconematerial, that is biocompatible and that can withstand the gastricenvironment. A silicone material also can also enable changes ofcurvature ranging between the elongated, narrower configuration of FIG.8, the intermediate configuration of FIG. 7, and the contracted, widerconfiguration of FIG. 6A. Like in the previous embodiments, firstoccluding member 102 is structured to be inserted in, and removed from,an organ such as the stomach when it is configured in the elongated,narrower configuration of FIG. 8 and after it has been placed in thestomach or other organ, to be reconfigured into the contracted, widerconfiguration of FIG. 6A. This change of configuration is achieved byhaving a string 106 disposed around and through device 94, inparticular, through first occluding member 102 and through lumens intether 100 and in distal member 98. Alternatively, string 106 may beconnected to the proximal end of first occluding member 102 and runthrough lumens in tether 100 and distal member 98. By pulling on string106 when first occluding member 102 is in the elongated, narrowerconfiguration of FIG. 8, struts 104 are caused to flex and to providefirst occluding member 102 with the rounder configuration of FIG. 7 andthen with the more bulbous configuration of FIG. 6A. The configurationof first occluding member 102 shown in FIG. 6A is maintained thanks to aconnecting member (not shown) that provides for a secure couplingbetween the proximal and distal ends of first occluding member 102.

Conversely, to revert from the configuration of FIG. 6A to that of FIG.8, a retainer (such as a string) coupling the connecting member with arelease member 108 is severed, in a manner similar to that described inrelation to the previous embodiments. In one variant of the presentembodiment, string 106 carries a number of spheres 110 or attachments ofother shapes that translate through an area having walls whereinterference is present between such spheres 110 and those walls. Suchinterference is overcome by the force applied to string 106 when it ispulled, but when such force is not present, the interference issufficient to block the translation of string 106 and stabilize theconfiguration of first occluding member 102. In other variants of thepresent embodiment, spheres 110 on string 106 engage one or more matinglocking devices, for example, one or more of mating locking devices 107,109, or 111 disposed in a longitudinal lumen through device 94proximally, in the middle, or distally of tether 100.

One skilled in the art will appreciate that struts 104 may bemanufactured from a variety of materials, including metallic and plasticmaterials, for example, silicones and shape memory materials. Oneskilled in the art will further appreciate that the materials may beimpregnated with a therapeutic material that is released in the stomachand/or gastro-intestinal tract over time, and that ancillary components,such feedback and radio transmitters or reservoirs of therapeuticmaterials, may also be included in device 94, as described with respectto the first embodiment.

FIG. 6B depicts a variant of the present embodiment, in which firstoccluding member 103 includes outer surface 105 (in the fashion of askin) that provides a smoother surface to the gastric mucosa.

A fourth embodiment of the invention is illustrated in FIG. 9. A keydifference between device 112 of the fourth embodiment and thepreviously described embodiments is that first occluding member 114 isshaped like a hollow ball having a plurality of openings 116, so that itcan be contracted longitudinally, to provide an elongated, narrowerconfiguration suitable for insertion and removal of device 112 into andfrom the stomach of a patient, or can be expanded laterally by pullingon a string running longitudinally through first occluding member 114,tether 118 and second occluding member 120, so to provide firstoccluding member 14 with a contracted, wider configuration.

One skilled in the art will appreciate that first occluding member 114may have a variety of other shapes equally appropriate for the intendedpurpose, for example, an ellipsoid shape, and that openings 116 also mayhave a variety of shapes, for example, hexagonal (as shown), polygonal,round or oval.

FIG. 10A depicts a fifth embodiment of the invention. Device 118 isrepresented only in its proximal portion, which includes apron member120, first occluding member 122 and the proximal portion of tether 124.First occluding member 122 is illustrated in greater detail in FIG. 10Band has an essentially semispherical outer surface 124, directedproximally (away from the pyloric valve after installation in thestomach) and a plurality of struts 126 that may be shaped as individualrods like the spokes of an umbrella, or as sheets, like the skins ofslices within an orange or the blades of a rotary fan. One of theadvantages of the present embodiment is the very smooth surfacepresented by outer surface 124 to the gastric mucosa.

While maintaining the descriptive similarity of first occluding memberwith an umbrella, it will be noted that first occluding member 124 maybe contracted to an elongated, narrower configuration in the fashion ofa closed umbrella during insertion of device 118 in the stomach or otherorgan, and may expanded to an expanded, wider configuration in thefashion of an open umbrella after installation to perform its foodblocking function at the pyloric valve. The transition from theelongated, contracted state to the expanded, wider state and vice versais achieved with the use of a string or equivalent joining product, forexample, by having a string 128 extend through one or more loops 130 (orrings or like extensions) on outer surface 124, then with both endsthrough a lumen (not shown) disposed in the axial direction of firstoccluding member 122, and then into a lumen within tether 124 thatcontinues within a second occluding member, in a manner similar to thepreviously described embodiments. Also like in the previously describedembodiments, the wider, expanded configuration of FIGS. 10A-10B may beretained by providing a connecting member that engages a correspondingcavity after first occluding member 122 has been fully expanded, and thewider, expanded configuration may be reverted to the narrower, elongatedconfiguration by severing the connection between the connecting memberand a release member coupled to the connecting member.

One skilled in the art will appreciate that various features may beadded to the present embodiment to improve usability, for example, theentry point of string 128 into outer surface 124 may be funnel shaped.Other features may also be added like in the previous embodiments, forexample, feedback and data transmission devices, or reservoirs fortherapeutic or selectively irritating substances. Further, device 118may be manufactured from a variety of materials including a resilientplastic with localized reinforcements, or with a plastic or metalmaterial admixed or coated with a therapeutic substance that elutes overtime.

FIGS. 11A-11B illustrate a sixth embodiment of the invention that bearsa number of similarities to the previous embodiment but also a fewdifferences, some of which are described hereinafter. Referring first toFIG. 11A, device 132 (illustrated only in its proximal portion) includesa first occluding member 134 that includes (see FIG. 11B) a central hub136 having a longitudinal lumen 154 therein, one or more struts 138, andoptionally, a connecting member 140 extending distally from hub 136.

First occluding member 134 may or may not include an outer surface 142,directed distally (towards the pyloric valve) with its cusp andproximally (towards the esophagus) with its open edge. As in theprevious embodiment, struts 138 extend radially from hub 136 and may beshaped like rods, in the fashion of wheels spokes, or like sheets, inthe fashion of fan blades.

Outer surface 142 (or hub 136 when outer surface 142 is not present) isconnected to the inner tip of the conical portion of apron member 144 bytubular member 146 that, in one embodiment, is essentially cylindricaland has a lumen running longitudinally along its length.

Connecting member 140 includes a rod portion 150 and a conical portion152, and secures first occluding member 134 in place by extendingconnecting member 140 into the lumen of tubular member 146, which has adiameter narrower than the diameter of the base of conical portion 152.Therefore, conical portion 152 travels along the lumen of tubular member146, eventually exiting it when pulled, for example by a string that isdisposed around and outside device 132, and then through the lumen 154of hub 136, then through the lumen of tubular member 146, and thenthrough the lumen of tether 148. The pulling action on the string causesfirst occluding member 134 to expand from an elongated, narrowerconfiguration suitable for introduction in the stomach through theesophagus to a wider expanded configuration suitable for maintainingapron member 144 in an expanded position.

Because conical portion 152 has a diameter narrower than the lumen oftubular member 146, conical portion 152 is prevented from travelingbackwards through the lumen of tubular member 146 once it has exitedthat lumen, locking first occluding member 134 in a wider, expandedposition. At the same time, in a manner like in the precedingembodiment, first occluding member 134 may be reverted from the wider,expanded configuration to the narrower, elongated configuration bysevering a link, for example a string that couples connecting member 140to a release member (not shown), thereby unlocking first occludingmember 134. Also like in the preceding embodiments, different types ofbiocompatible and gastric-resistant materials may be employed tomanufacture device 132, and different optional accessories, such asfeedback and data controllers and substance reservoirs, may be includedinto device 132.

One of the advantages of the present embodiment lies in the structure offirst occluding member 134, which enables an easy changeover from theelongated configuration to the expanded configurations and vice versa,and in the distal orientation of the cusp of outer surface 142 (whenincluded), or in the shape and disposition of first occluding member 134within apron member 144, which increases the occluding strength ofdevice 132 against the pyloric valve.

FIGS. 12A and 12B depict a seventh embodiment of the invention, in whicha device 156 again includes a proximal member 158 connected to a distalmember 160 by a tether 162. In turn, proximal member 158 includes anapron member 164 that surrounds struts 166, which may be shaped asspokes (in the fashion of umbrella spokes) or have a more extended,arched perimeter like longitudinal slices of a cone that encompasses atleast a portion of the inner perimeter of apron member 164. Moreparticularly, FIG. 12A shows device 156 with struts 166 in an openposition, engaged by a base 168 (shown in FIG. 12A in two positions, oneas it approaches struts 166 and the other as it has contacted andengaged struts 166), which has a wider portion 170 and an elongatedportion 172. Base 168 has an axial lumen, extending at least through thewider portion 170, dimensioned to engage rod 174 (FIG. 12B) that extendsproximally from the distal end of apron member 164, at its conical tip,into the interior of proximal member 158. As base 168 travels towardsthe interior of proximal member 158, in the direction of rod 174 (FIG.12B), struts 166 are forced to diverge and provide lateral support toapron member 164, thereby causing proximal member 158 to transition froman elongated, narrower configuration suitable for introduction into thestomach from the esophagus or into another organ, to a wider, expandedconfiguration suitable for occluding the pyloric valve. Base 168 isretained in a position mated with rod 174 by becoming restrained byretainers 176, suitably angled to promote the movement of base 168towards rod 174, and to restrain the translation of base 168 in theopposite direction.

Like in the previous embodiments, proximal member 158 may transitionfrom the narrower, elongated configuration to the wider, expandedconfiguration by pulling on an end of a string (not shown), whichtravels outside and along device 156 and into the lumens of base 168,rod 174, tether 162 and distal member 160. Base 168 may also include, inits interior portion, a connecting member that engages a mating cavity(for example, by interference fit) to rod 174, or by other engagementsknown to a person skilled in the art.

Conversely, base member 168 may be disengaged from struts 166 by pryingstruts 166 open and by releasing base 168 from retainers 176. If base168 also is retained in place by a connecting member, the disengagementof base 168 to revert device 156 to the elongated, narrowerconfiguration involves the severing of a coupling (for example, astring) between the connecting member and a release member, in a mannersimilar to that described for the previous embodiments. Also as for thepresent embodiments, device 156 may be manufactured from a variety ofmaterials that are biocompatible, resistant to the gastric environmentand that do not cause erosions of the pyloric wall. Device 156 also mayinclude feedback or data transmission devices or reservoirs oftherapeutic or predetermined irritating substances.

FIGS. 13A-13B depict an eighth embodiment of the invention. Device 178includes a proximal member 180 and a distal member 182, connected by atether 184, as in the previously described embodiments, but does notinclude a first occluding member within apron member 186, contrary tothe previously described embodiments. Instead, apron member 186 includesa coil 284 embedded within its wall 286. Coil 284 may have a variety ofconfigurations, for example helical, or be formed by a plurality ofparallel circles connected by transversal members so that when one ormore of the parallel circles is pulled on, the transverse members causethe circles to become separated one from the other longitudinally and toform a cage-like structure. The helical configuration instead may bedelivered coiled on itself to provide for a narrower diameter, givingapron member 186 a narrow, elongated configuration, which may bereleased after introduction in the stomach to give apron member 186 awider, expanded configuration.

Removal of device 178 from the stomach, or from another organ in whichit may be disposed, requires that device 178 be collapsed to assume anelongated, narrower configuration again. Because reverting coil 284 tothe configuration with a narrower diameter may be a rather complexoperation if performed through the esophagus when coil 284 is providedwith the helical configuration, device 178 includes a tear line 288, sothat, by pulling on one end of coil 284, for example, on ring 290attached to one end of coil 284, coil 284 rips through tear line 288 andbecomes extended, enabling a clinician to remove it in essentially wireform. The remainder of device 178 can then be removed together with coil284, for example by having the remainder of device 178 remain attachedto coil 284 after coil 284 has torn tear line 288, or may be removedseparately from coil 284.

Like in the previous embodiments, a variety of materials may be used tomanufacture device 178 and a variety of ancillary device may also beprovided, which will not be described here again for the sake ofbrevity. In particular, coil 284 may be manufactured from a plasticmaterial, such as nylon or polypropylene, or from a metallic materials,such as stainless steel or a shape memory material.

FIGS. 14A-14C and 15A-15D depict a ninth embodiment of the invention.Device 188 includes, like in the previously described embodiments, aproximal member 190 and a distal member 192 connected by a tether 194.In this embodiment, however, apron member 196 is foldable along a creaseor living hinge 198 that extends along at least a portion of thecircumference of the proximal, essentially cylindrical portion 200.Proximal portion 200 may have a wall of constant section, as shown inFIG. 14A, or of arched cross-section, as shown in FIG. 15A.

During delivery to a target organ, for example, through the esophagus toreach the stomach, proximal portion 200 is extended, as shown in dashedlines in FIG. 15A and in FIG. 14B. A coupling device, such as a string,is connected at one or more points to the free edge of proximal portion200, for example, at two points 202, and travels toward the inner tip ofdistal (conical) portion 204 of apron member 196, where it engagesconnecting member 206, and then extends into lumens disposed withintether 194 and distal member 192.

FIGS. 14A and 14C and FIGS. 15A-15D illustrate different shapes andmechanisms by which connecting member 206 may become locked with matingcavity 208. More particularly, FIG. 14C illustrates connecting member210 coupled with release member 212 by a connector, such as a string214. Connecting member 210 is shaped to be engaged in a mating cavity216, which is situated within support member 218 that is positioned atthe internal tip of the distal (conical) portion of apron member 196. Asa consequence of the engagement of connecting member 210 with matingcavity 216, apron member 196 becomes locked in place in itsconfiguration with folded, adjacent walls in its proximal (cylindrical)portion 200. Conversely, to extract device 188 from the target organ(for example, to extract device 188 from the stomach through theesophagus), the connector between connecting member 210 and releasemember 212 is severed, reverting device 188 to its elongated, narrowerconfiguration (shown in FIG. 14B) and facilitating extraction.

FIGS. 15C-15D illustrate variants of connecting member 210. Moreparticularly, FIG. 15B illustrates a variant, in which connecting member220 includes three annular portions disposed on a rod that becomeengaged with a correspondingly shaped mating cavity. FIG. 15Cillustrates connecting member 222 as having two instead of three annularportions, but a person skilled in the art will appreciate thatconnecting members can be provided having substantially any number ofannular portions. FIG. 15D illustrates connecting member 224 as having ascalloped profile, in which a number of ridges 226 are disposed on a rodmember. Mating cavity 228 contains grooves 230 that have shapes matchingthose of ridges 226. In particular, in one variant of this embodiment,ridges 226 are inclined, so to facilitate insertion into mating cavity228 but also to hinder removal. Instead, the walls of proximal portion200 become released and can extend as in FIG. 14B by severing theconnection between connecting member 224 and release member 232, forexample, by severing string 234 in a manner similar to that of theprevious embodiments.

One of the advantages of the present embodiment is that there is nofirst occluding member, providing for device 188 to have a lower massthan some of the previously described embodiments, and therefore to belighter and less rigid, irritating the stomach less, and in particular,irritating the pyloric valve less. Like the preceding embodiments,device 188 may be manufactured from a variety of materials and may alsobe equipped with a number of accessory components for feedback and datatransmission and for substance elution. Such materials and accessorieswill not be described again here for the sake of brevity.

FIGS. 16A-16B and 17 depict a tenth embodiment of the invention, inwhich a device 236 includes a proximal member 238 and a distal member240 connected by a tether 242. Like previously described embodiments,proximal member 238 includes an apron member 244 and a first occludingmember 246, which, in the present embodiment, has a shape reminiscent ofthe letter “Y,” in particular, has a stem portion 248 extending from theinner conical tip of apron member 244 (which corresponds to the proximalend of tether 242) to support a curved element 250, typically asemi-circular or semi-elliptical element. More particularly, FIG. 16Ashows that curved element 250 has a reinforced, double-layered structureformed by having an outer layer 252 assume the curvature of a base layer254, as shown in FIG. 17. This “cup within a cup” structure provides foran easy insertion into an organ such as an easy insertion into thestomach from the esophagus while device 236 is in the configuration ofFIG. 17, but also provides for a firm, more rigid structure in theconfiguration of FIG. 16A, due to the layered structure of curvedelement 250. The changeover from the structure of FIG. 17 to that ofFIG. 16 is enabled by providing a string 256, coupled to outer layer252, to travel through lumens into stem 248, tether 242 and distalmember 240. As shown in FIG. 17, string 256 may be coupled with outerlayer 252 in two points, but one skilled in the art will appreciate thatstring 252 may be coupled in one or more points. FIGS. 16B and 17further show that a recess is carved in outer layer 252 to house arelease element, which, like in the previous embodiments, is used tounlock first occluding member 246 prior to removal from the stomach orother organ. Alternatively, string 256 may be connected to one or moreloops or rings 270 at the periphery of outer layer 252 and travelthrough a conduit within outer layer 252, exiting that conduit in thearea shown in FIGS. 16A-16B.

Outer layer 252 is locked against base layer 254 by pulling on string256 (for example, by pulling on snare ball 258), and by havingprotrusions 260 extending from string 256 engage a locking ring 262disposed in the lumen either of stem 248 (as illustrated in FIGS. 16Aand 16B) or of tether 242 (as illustrated in FIG. 18, in relation to asimilar embodiment). Protrusions 260 are shown as spherical protrusionsin the illustrated embodiment, but one skilled in the art will recognizethat other shapes are also possible.

FIG. 18 depicts an eleventh embodiment of the invention, in which device264 is constructed similarly to device 236, except that first occludingmember 266 is not composed of two separate and distinct layers attachedto a stem, but instead includes two layers attached to a stem that areformed by having a closed member 268 fold on itself in the manner of adeflating ball. One of the advantages of device 264 over device 236resides in the smooth edges of first occluding member 266, as opposed tothe sharper edges of curved element 250 in device 236. Living hinges orcreases that facilitate the folding process may be optionally provided.Locking and unlocking mechanisms are the same as for device 236 and forboth devices 236 and 264. A variety of materials and accessorycomponents may be envisioned, in the same manner as for the precedingembodiments.

Embodiments 236 and/or 264 may be selectively reinforced in certainareas. For example, if embodiments 236 and/or 264 were made of asilicone material, a fabric insert may be inserted in the areasurrounding release element 269, to decrease the risk of tear in thatarea.

FIG. 19 depicts a twelfth embodiment of the invention. Device 272includes a proximal member 274 and a distal member 276, connected one tothe other by a tether 278. In turn, proximal member 274 includes anapron member 280, shaped like in the previously described embodiments,and a first occluding member 282 that has a bulbous shape, made of arolled layer in the fashion of a snail shell as described in U.S. patentapplication Ser. No. 11/702,888. For introduction into an organ (forexample, introduction into the stomach through the esophagus), firstoccluding member 282 is distended (not rolled up), providing device 272with a narrower, elongated shape. In the distended, elongated state,first occluding member 282 exhibits a wider, more bulbous base and anarrower, tongue-like extension. As shown in FIGS. 20A-20C, a stringextends from the tip or an intermediate point of the tongue-likeextension and may travels through an opening in and across the base sothat when the string is pulled, the tongue-like extension rolls onitself and causes first occluding member 282 to assume its contracted,wider configuration shown in FIG. 19. A button-like retaining member onthe tongue-like extension eventually travels through and engages theopening in the base, locking first occluding member 282 in thecontracted configuration. That button-like retaining member may besevered from first occluding member 282, enabling first occluding member282 to revert to its elongated, narrower shape.

Alternatively, as shown in FIGS. 21A-21B, the string may originate fromthe base of first occluding member 282 and travel to exit firstoccluding member 282 at the tip of the tongue-like extension, so that apulling of the string causes first occluding member 282 to roll onitself and acquire the contracted configuration, eventually securing thestring to a release member. In this alternate design, first occludingmember 282 may revert to the elongated, narrower configuration either bysevering the release member, or by pulling on the release member and bycausing the string to cut through a tear line, opening up firstoccluding member 282, as shown in FIGS. 22A-22C.

The following Example relates to the procedure for implanting andexplanting a trans-pyloric device, such as device 30 described above, inthe stomach of a dog.

TABLE I STEP # DEVICE IMPLANT PROCEDURE 1 Anesthetize fasted dog andplace on table. 2 Ensure that the long endoscope will be used (Olympusmodel CF Type 100 TL or equivalent). 3 Insert video tape into endoscopyequipment. 4 Place endoscope through the esophagus, and into thestomach. 5 Drain stomach contents and inflate the stomach. 6 Make sureendoscope video is recording throughout the entire procedure. 7 Performthorough baseline endoscopic analysis of the stomach, looking for anypreexisting erosions or ulcerations paying particular attention to thelower esophageal sphincter, the antral region, and the proximal pylorus.Document findings on device insertion worksheet. 8 Place the scopethrough the pyloric cylinder to rule out incompetent and/or patulouspylorus. Inspect the lining of the duodenum and duodenal bulb forevidence of erosion and/or ulceration. Document findings on deviceinsertion worksheet. 9 Pull endoscope back out of pylorus to the GEjunction (scope just entering the stomach). 10 Record the endoscopedepth at the GE junction on the device insertion worksheet. 11 Markdepth of GE junction on the delivery device with respect to the proximalend of the pod (using colored tape). 12 Record device ID on the deviceinsertion worksheet. 13 Lubricate the delivery device along its lengthwith surgical jelly. 14 Insert delivery device until GE junction mark isreached. This will ensure that the pod is fully within the stomach. Ifnecessary, insert delivery catheter until resistance is felt and removestiff pod closure rod from half of the delivery pod length. Then advancedelivery device until proximal portion of the pod is past the GEjunction. 15 Insert endoscope beside delivery device - obtain image ofpod in the stomach. 16 Remove the stiff pod closure rod to fully releasethe device from the pod. 17 Pull the pull-ring until locking indicatoris visualized; this will lock the implant. 18 Cut the red fiber and pullthe ring to remove pull cord. 19 Examine the stomach lining to ensurethat no gross tissue damage has been caused by the placement and removalof the device and delivery system. Inspect the stomach body, antrum, andpylorus for evidence of erosion, laceration, or other forms of damageand record observations on the device placement worksheet. 20 If distalbulb remains in the proximal portion of the delivery pod, utilize theendoscope to manipulate the distal bulb clear of the delivery pod. 20Slowly remove the endoscope. 21 Remove delivery system. 22 Awaken andrecover animal.

The animal will be then be recovered and housed. Once the veterinariandetermines that the animal's recovery is complete, the animal will bemoved to a housing facility in an individual run. Water will beavailable ad libitum. Animal feed, per scheduled feeding, may includeprophylactic antibiotics to protect against respiratory infection.

TABLE II STEP # DEVICE EXPLANT PROCEDURE 1 Anesthetize fasted dog andplace on table. 2 Ensure that the long endoscope will be used (Olympusmodel CF Type 100 TL or equivalent). 3 Insert video tape intoFluoroscopy Equipment. 4 Insert video tape into endoscopy Equipment. 5Place endoscope through the esophagus and into stomach. 6 Make sureendoscope video is recording. 7 Record position of device (transpyloric,fully intragastric or not visible from gastric space, on the deviceremoval worksheet. 8 Perform thorough endoscopic analysis of gastricspace looking for erosions or ulcerations paying particular attention tothe lower esophageal sphincter, the proximal pylorus and the antralregion of the stomach. 9 If device was not visible from gastric space in7, enter duodenum and search for implant, if found, return to line 10,if not found, perform fluoroscopy to locate implant and go to line 22.10 Cut the string at the top of the TPS to release the lockingmechanism. Insert loop snare (240 mm) into working channel of endoscopeand snare device retrieval ball. 11 Using the snare, position theretrieval ball 3-4 cm away from the distal end of the endoscope. 12Maintain firm grip around retrieval ball with the snare. 13 Removeendoscope while maintaining the position of the snare with respect tothe endoscope, such that the implant follows the endoscope out throughthe esophagus. As the implant is retrieved, the esophageal orifice willcause the unlocked spiral to unfurl. The shell will collapse at thelower esophageal sphincter and the entire device will be removed alongwith the endoscope. 14 If device remains in animal, repeat steps 10-13.15 Rinse the implant with water to remove any remaining stomachcontents. Label the device with the animal ID number and date and timeof removal, and place in Ziplock bag for analysis. Note any issues withdevice removal or any observations made during the removal procedure onthe Device removal worksheet. 16 Place the endoscope back through theesophagus into the stomach. 17 Advance endoscope across pylorus into theduodenum. 18 Perform thorough endoscopic analysis of proximal 10 cm ofduodenum looking for erosions or ulcerations paying particular attentionto the distal pylorus and the duodenal bulb. 19 Remove endoscope andcontinue. 20 Wake animal and return to cage.

An endoscopic evaluation procedure of the implanted device is describednext.

After standard fast, with water provided ad libitum the dog will bebrought into a purpose-built operating room, which will include anoperating table and anesthetic machine with CO₂, respiratory, a pulserate monitor, and a ventilator. Anesthesia will be titrated to maintainthe dog at the appropriate level of anesthesia for an endoscopicprocedure as determined by the veterinarian. All animals studied will bemonitored for end-tidal volume CO₂, respiratory rate, and pulse ratethroughout the anesthetic procedure. After induction, the dogs will beintubated endotracheally and endoscopy will be performed.

Cursory endoscopic evaluation will be performed on animals in ControlGroup 4 in order to ensure similar treatment as animals in Groups 1, 2,3 and 5. Thorough endoscopic evaluation will be completed on all animalsin Groups 1, 2, 3 and 5 until they are terminated from the studyaccording to the following protocol:

TABLE III STEP # ENDOSCOPIC EVALUATION PROCEDURE 1 Anesthetize fasteddog and place on table. 2 Ensure that the long endoscope will be used(Olympus model CF Type 100 TL or equivalent). 3 Insert video tape intoendoscopy equipment. 4 Place endoscope through the esophagus, and intothe stomach. 5 Drain stomach contents and inflate the stomach. 6 Makesure endoscope video is recording throughout the entire procedure. 7Perform thorough endoscopic analysis of the stomach, looking for anyerosions, ulcerations, fibrosis, stenosis, scarring, webbing or atresia,paying particular attention to the lower esophageal sphincter, theantral region, the gastric and duodenal pyloric regions and the duodenalbulb. Document findings on endoscopic evaluation worksheet. 8 In theevent of ulceration, assign the ulceration a grade and biopsy, ifrequired. Document findings on endoscopic evaluation worksheet. 9 If adevice is present, document its orientation and position on theendoscopic evaluation worksheet. 10 If a device is present, performthorough analysis of the device including assessment of: 1) theintegrity of the shell, tether, central spiral and, if visible, distalbulb, 2) the state of the snare ball including absence or presence oftension in locking cord and any protrusion of the snare ball out of thecentral depression. Document findings on endoscopic evaluationworksheet. 11 If a device is present, record the presence and locationof any foreign materials within the device (such as trapped fibers) andany notable discoloration. Document findings on endoscopic evaluationworksheet. 12 Slowly remove the endoscope. 13 Awaken and recover animal.

The animals will then be recovered and housed. Once the veterinariandetermines that the animal's recovery is complete, animals will be movedto a housing facility in an individual run. Water will be available adlibitum. Animal feed, per scheduled feeding, may include prophylacticantibiotics to protect against respiratory infection or proton pumpinhibitors to treat diagnosed ulceration.

FIGS. 23A-23C, 24A-24C, 25A-25C, 26A-26C, 27A-27C, and 28A-28Dillustrate methods of implanting a device in the stomach or other organbased on inflating the device or otherwise having the device increase insize in the stomach from a smaller volume during insertion. Thesefigures should be understood to have a generic illustrative purposeonly, and that the specific shapes of the devices as disposed in thegastrointestinal tract are to be selected among those described in theprevious embodiments.

More particularly, FIGS. 23A-23C illustrate a device introduced in thestomach or other part of the gastro-intestinal tract in an elongatedconfiguration (FIG. 23A), which is expanded to an intermediate (FIG.23B) and eventually a final configuration (FIG. 23C) by injecting a foamwith an appropriate catheter, causing a volume expansion.

FIGS. 24A-24C illustrate a process similar to that of FIGS. 23A-23C,except that a substance such as water, a reagent and/or a catalyst, isinjected through the catheter, which upon contact with a product alreadypresent in the device causes a volume expansion of that product.

FIGS. 25A-25C illustrate schematically a mode of placement of thedevices of FIGS. 23A-23C and 24A-24C through a catheter introducedthrough the esophagus (FIG. 25A), then used for infusing foam or agrowth substance (FIG. 25B), causing the device to become fully inserted(FIG. 25C). Conversely, FIGS. 26A-26D illustrate the removal of thatdevice by showing the device in its placed state (FIG. 26A), theattachment of a device extractor (FIG. 26B), the activation ofpredetermined failure points (FIG. 26C), and the extraction of thedevice (FIG. 26D).

FIGS. 27A-27C illustrate other embodiments, in which multiple distalbulbs (FIG. 27A) or a larger distal bulb (FIG. 27B) may be present toslow transit of food in the gastrointestinal tract, or in which nodistal bulb may be present and the device can act as a space filler(FIG. 27C).

In particular, FIG. 27C illustrates device 293, which is configured asan occluding member that resides in a stomach 295. Device 293 has notether and no second occluding member and in that respect, device 293show a variant possible for all embodiments of the invention, namely,that while the embodiments described hereinbefore and hereinafter havebeen illustrated as including a proximal member, a distal member and atether, the distal member and/or the tether may be not be included invariants of those embodiments. For example, a variant of embodiment 30may include only proximal member 32, or proximal member 32 and distalmember 34 connected one to the other without tether 36, or with a tether36 of different lengths and configurations. For example, tether 36 mayconnect multiple distal members as in the structure of device 291 inFIG. 27A.

Additionally, device 293 may include one or more elements structured toalert the patient or a clinician or other attending personnel of afailure of the device, whether such failure is real or potential. Forexample, a signal may be transmitted that alerts the patient or otherattending personnel of the breach of wall 297 of device 293, makingdevice 293 at risk of migrating from stomach 295 and of passing intoduodenum 299, both losing its functionality in the stomach andnegatively affecting the functionality of the intestinal tract,typically ending up expelled from the patient's body as feces. Such asignal may be provided by the activation of an eccentric motor or of amechanical, electric or electronic alarm system associated with theintegrity of wall 297. For example, changes in pressure, mechanicalshape, conductivity, capacitance, resistance, pH, or optical propertiesof a fluid contained in device 293, or the activation of electric orelectronic monitoring systems associated thereto, may trigger such asignal.

In one variant of the present embodiment, device 293 includes a patch301 designed to plug an inflation opening in the outer shell or wall 297of device 293. More particularly, patch 301 defines a discrete region ofincreased hardness and/or thickness, through which device 293 may beinflated or filled. In this variant, an alert system 303 may interactwith shell 297 of device 293 in any region of shell 297 or only withpatch 301. Alert systems of this kind are disclosed in PCT patentapplication WO 2006/135857, which are incorporated herein by reference.

In its simplest variant, device 293 is filled with a non-conductiveaqueous medium (for example, with polyethylene glycol or with anothernon-conductive, osmotic hydrophilic material dissolved in de-ionizedwater), and alerting system 303 simply monitors the conductivity orother electrical properties of the fluid, which will change dramaticallywhen a breach occurs in shell 297 of device 293. Alternatively, device293 may incorporate two electrodes on patch 303, one of which facesexternally and the other one internally, such that a voltage applied toone electrode is only sensed by the other electrode if there is a breachin shell 297, which is built of a highly insulating material such assilicone. In this variant, device 293 may include a battery withlongevity greater than implant duration, as well as an alerting system303 (such as an eccentric motor, a radio-frequency alert system, or anacoustic generator) to alert the patient or attending personnel that abreach has occurred.

FIGS. 28A-28C further illustrate the mode of use of a gastric fillingdevice designed to increase in volume in the stomach. In particular,FIG. 28A shows insertion of the device, FIG. 28B shows inflation of thebulbs, and FIG. 28C shows the intestinal migration of the distal bulb.FIG. 28D instead shows that obesity treatments may be enhanced by addinggastric fillers in the stomach.

FIGS. 29A-29C illustrate a thirteenth embodiment of the invention, inwhich device 292 includes a proximal member 294 that is connected to adistal member by a tether (both not shown) in the same manner as in thepreviously described embodiments. In turn, proximal member 294 iscomposed of an apron member 296 that surrounds a first occluding member298, disposed in an essentially central position within apron member296.

First occluding member 298 is structured to be formed from an elongated,single layer configuration used during the insertion process into thestomach or other organ of a patient to a telescoping, multi-layeredconfiguration after implantation in the stomach or other organ isachieved. More particularly, first occluding member 298 includes adistal part 300, a central part 302, and a proximal part 304, which, invariants of this embodiment, may be divided one from the other by livinghinges 306, or by creases, or by slots, or by localized thinnings of thewall of first occluding member 298, or may just be folded one onto theother when pressure is applied on proximal part 304.

Proximal part 304 includes a proximal protrusion 308, extending in adirection opposite to the tether, a distal protrusion 310, extending inthe direction of the tether and shaped to interference fit within matingcavity 312, and a body 314, supporting proximal protrusion 308 anddistal protrusion 310 at opposite ends. The interference fit betweendistal protrusion 310 and mating cavity 312 causes first occludingmember 298 to maintain its contracted shape after the telescopic foldingof proximal part 304, central part 302 and distal part 300 one onto theother. This may be achieved by compressing proximal protrusion 308distally, for example with a catheter inserted into the stomach andpushing in the direction of the tether, or by having a connector (suchas a string) run through mating cavity 312 and through a lumen in thetether and in the distal member, to enable a clinician to pull distalprotrusion 310 into mating cavity 312. In a variant of the presentembodiment, as well as in variants of the previously describedembodiments, the string may exist device 292 not through the distalmember, but from an opening situated in the tether in device 292.

When it is desired to remove device 292 from the stomach or other organ,first occluding member 298 can be unfolded to regain its elongated,narrower configuration in different ways. In one variant of the presentembodiment, first occluding member 298 can be unfolded by simply pullingon proximal protrusion 308, thereby overcoming the interference fitbetween distal protrusion 310 and mating cavity 312. In another variantof the present embodiment, proximal protrusion 308 and distal protrusion310 are coupled one to the other by a connector, such as a string, sothat when that connector is severed (for example, by cutting thestring), proximal protrusion 308 and distal protrusion 310 becomeuncoupled, with distal protrusion 310 remaining contained within matingcavity 312 while proximal protrusion 308 extends outwardly.

FIG. 29B illustrates the same embodiment of the invention as shown inFIG. 29A, except that distal protrusion 316 and mating cavity 318 do nothave cylindrical shapes, or, more general, the shapes of aparallelepiped, as in FIG. 29A, but instead have more expanded shapes,for example, have the shape of a sphere supported by a cylinderillustrated in FIG. 29B, thereby providing for a tighter interferencefit than in the embodiment shown in FIG. 29A. One skilled in the artwill appreciate that distal protrusion 316 and mating cavity 318 may beshaped in a variety of other shapes as well, all which fall within theshape and scope of the present invention.

FIG. 29C further illustrates the similar embodiment of the invention asshown in FIG. 29B, except that no proximal or distal protrusions arepresent. More particularly, FIG. 29C illustrates the transformation ofproximal member 320 from the elongated, narrower configuration shown onthe left hand side to the wider, contracted configuration shown on theright hand side, and also shows how such transformation may be attainedby pulling on a string 322, which may be connected in one or more pointsto the proximal end 324 of proximal member 320. In its low-profiledelivery configuration, occluding member 342 may be attached viacircular wall sections which may evert or fold upon themselves to formthe deployment configuration shown. In this particular example, firstwall section 330 (having an average thickness of, e.g., 2 mm) may extendat an angle to first interlockable wall section 334 (having an averagethickness ranging from, e.g., 1 to 3 mm). A second interlockable wallsection 338 (also having an average thickness ranging from, e.g., 1 to 3mm) may extend from first interlockable wall section 334 with acomplementary wall section 332 (having an average thickness of, e.g., 2mm) with occluding member 342 attached thereto.

When reconfigured for deployment, occluding member 342 may be urged viastring 322 towards its distal end such that second interlockable wallsections 338 may rotate and evert about hinged region 326, e.g., livinghinge, such that first wall surface 336 and second wall surface 340 comeinto apposition relative to one another and complementary wall section332 pivots about hinged region 328 to come into contact against firstwall section 330.

The apposed first and second interlockable wall surfaces 334, 338 may beconfigured along their interface 344 to temporarily or permanentlyadhere to one another, e.g., via an adhesive, as illustrated in thecross-sectional end view of FIG. 30A. Alternatively, each of therespective surfaces may define surface features, e.g., interlockingridges 346, which interdigitates relative to one another to prevent orinhibit the unfolding or unlocking of the device back into itslow-profile configuration, as illustrated in the cross-sectional endview of FIG. 30B.

A device constructed according to the principles of the presentinvention (as described through a number of representative embodiments)is suited not only for the treatment of obesity, but also for treatingother ailments. Examples of such treatments include treatments torestore normal glucose tolerance to a diabetic or prediabetic subject,or to delay or prevent the progression of diabetes in a subject byinhibiting fasting insulin secretion or glucose-stimulated insulinsecretion. Other examples of such treatments include the treatments ofpatients suffering from one or more diseases characterized by obesity,including hyperphagia, dyslipidemia, Prader Willi syndrome, Froelich'ssyndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesensyndrome, Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II,III, and IV.

While an example of use of the present invention for the treatment ofdifferent ailments has been described with reference to the firstembodiment (device 30), the other embodiments described herein areequally suitable for the treatment of those types of diseases.

Also as previously mentioned, a number of ancillary components may beincluded in a device constructed according to the principles of thepresent invention, for example sensors or transmitters that providefeedback and other data to an intra-corporeal or extra-corporealprocessor. The device of the present invention may also be structured torelease a therapeutic substance to treat predetermined conditions, or amildly irritating substance that is released when an undesirablesubstance (for example, sugar) is detected in the stomach or in theorgan where the device is disposed. Such a substance may be contained ina reservoir and be dispersed in the gastro-intestinal tract either overtime, or upon opening of the reservoir by a sensor. Alternatively, sucha substance may be coated on the device, or may be impregnated on thesurfaces of the device or within pores on the device, admixed with theconstituent materials of the device, for example with a resin, to bereleased over time upon contact with gastric substances.

This embodiment, as well as any other embodiment discussed herein, maybe functional in the fully gastric or in the transpyloric position, andmay or may not include an element designed to span the pylorus.Accordingly, any of the aforementioned functions of this or any otherembodiments may be accomplished with a shape-memory, locking orinflatable structure that is designed to reside fully and solely withinthe gastric space.

In addition, when any of the embodiments described herein has a lockingcapability (for example, by using a string to engage a connecting memberwith a mating cavity, and/or by using a string to connect the connectingmember to a release member such that a severing of the string causes thedevice to lose its locked, bulbous configuration), an alerting elementmay be employed to detect a reduction in tension of the locking stringand to alert the user of such anomaly. In the embodiment depicted inFIGS. 1A-1E, an alerting element may be employed to monitor the tensionof the string that causes connecting member 56 to couple with matingcavity 64, or to monitor the tension of the string that couples releasemember 58 to connecting member 56. Similar arrangements may be employedfor all the other embodiments of the invention described herein.

More particularly, a reduction in string tension may be used as anindicator of a failure of the locking mechanism of the device, and usingtechniques similar to those described above with reference to FIG. 27C,this failure may be reported to the patient or to attending personnel toprovide for a rapid removal of the device from the stomach.

String tension in the string may be measured in a variety of ways, forexample, by tensioning a spring element in line with the string, so thattwo electrodes will come into contact if the string shortensunexpectedly. This string shortening may generate a local signal, forexample, a vibration or an acoustic sound, or may be reportedexternally, for example via radio-frequency communication.

Such element for detecting string tension may be battery powered, with apower source having a usable life that spans the entire duration of theimplant, or may be rechargeable, either through an endoscopically-guidedcatheter introduced in the stomach of the patient or wirelessly. Suchdetection element also may be used to ensure that the locking string hasbeen sufficiently deployed by causing the device to provide a feedbackthat the device has been fully loaded once the lock has come undersufficient tension.

One method of disease treatment of particular interest based on a deviceaccording to the present invention is the release of insulin, achievedby disposing an insulin reservoir in the second occluding member (forexample, in device 30, in second occluding member 34), which becomespositioned in the gastro-intestinal tract after implantation of thedevice. Such a release of insulin may be controlled passively, forexample, by choosing an orifice of a certain size to control flow fromthe reservoir into the outer environment, or may be controlled actively,for example, may be timed by a time-controlled actuator as known in theart, or may be actuated by one or more sensors, for example in responseto the detection of sugar in the gastro-intestinal tract. In oneembodiment, insulin may be released by having the one or more sensorsactuate a pump. In another embodiment, release of insulin may beactuated extra-corporeally, by the patient, by a clinician or by anautomatic device upon the wireless reception of certain data from asensor implanted in the body, for example, when sugar level in a portionof the intestine exceeds a certain level. In still another embodiment, afeedback may be provided to the patient or to attending personnel thatis related to the conditions causing the release of insulin, and/or tothe amount and speed of release of the insulin.

Such ability to release insulin makes a device according to the presentinvention suitable for the treatment of obesity, diabetes and otherdiseases not only by providing insulin or other compound in thegastro-intestinal tract, but also through the combination of theoccluding action of the proximal member and the release of the compoundstored in the device.

More particularly, diabetes may be treated not only through thedispersion of insulin in the gastro-intestinal tract (a direct therapy),but through the combination of insulin dispersion and the slowed gastricemptying causes by the present device, which reduces the requirement forinsulin supply (an indirect therapy). Diabetes may also be treated byproviding insulin at the required intervals to patients that are eitheraverse to other delivery methods (for example, that are averse toinjections) or that are non-compliant due to inability or lack of desireto maintain the required schedules.

Conversely, obesity may be treated by use of the present device not onlyby reducing food entry into the intestinal tract by the intermittentoccluding action on the pyloric valve and by reducing appetite due tothe feeling of satiety induced by having the present device reside inthe stomach, but also by dispersing insulin in the patient'sgastro-intestinal tract, especially in the more morbid cases of obesity.

While the invention has been described in connection with the abovedescribed embodiments, it is not intended to limit the scope of theinvention to the particular forms set forth, but on the contrary, it isintended to cover such alternatives, modifications, and equivalents asmay be included within the scope of the invention. Further, the scope ofthe present invention fully encompasses other embodiments that maybecome obvious to those skilled in the art and the scope of the presentinvention is limited only by the appended claims.

1. A device for intermittently obstructing a gastric opening, the devicecomprising: a proximal member including a first occluding member and anapron member, and a distal member including a second occluding memberconnected to the proximal member with a tether, wherein the firstoccluding member is formable from an elongated, narrower configurationto a contracted, wider configuration, and wherein the apron member has aproximal open end surrounding the first occluding member and a distalclosed end connected to the tether.
 2. The device of claim 1, whereinthe proximal end of the apron member is spaced from the first occludingmember by an interstice.
 3. The device of claim 1, wherein the firstoccluding member is formable from the elongated, narrower configurationto the contracted, wider configuration by injecting a substance withinthe first occluding member.
 4. The device of claim 1, wherein theelongated, narrower configuration is a helical configuration having aplurality of turns, and wherein the contracted, wider configuration isformed by nesting the turns one adjacent to the other.
 5. The device ofclaim 4, wherein the first occluding member is reversibly formable fromthe elongated, narrower configuration to the contracted, widerconfiguration.
 6. The device of claim 4, wherein the first occludingmember is formable from the elongated, narrower configuration to thecontracted, wider configuration by causing a connecting member at afirst end of the first occluding member to couple with a second end ofthe first occluding member.
 7. The device of claim 6, wherein theconnecting member is coupled to the second end by engaging theconnecting member in a mating cavity at the second end.
 8. The device ofclaim 6, wherein the connecting member is coupled to the second end bydrawing distally a string connected to the connecting member.
 9. Thedevice of claim 8, wherein the string extends along the length of thedevice within a lumen extending from the first to the second occludingmembers through the tether, wherein the string is looped through theconnecting member, and wherein the string is removable from the deviceafter the connecting member has engaged the second end.
 10. The deviceof claim 8, wherein the string comprises a portion having a first colordifferent from a second color of a remainder of the string.
 11. Thedevice of claim 6, wherein the first end is reinforced by including of areinforcing material in the first end having higher mechanicalproperties than the remainder of the first occluding member.
 12. Thedevice of claim 6, wherein the first occluding member is reversible fromthe contracted, wider configuration to the elongated, narrowerconfiguration by severing the connecting member from the first end. 13.The device of claim 1, wherein the device is manufactured from aresilient plastic material.
 14. The device of claim 1, wherein the apronmember is reversible from surrounding the first occluding member tosurrounding a proximal portion of the tether.
 15. The device of claim 1,wherein the apron includes a proximal essentially cylindrical portionand a distal essentially conical portion connecting the proximal portionto the tether.
 16. The device of claim 14, wherein the proximal portionand the distal portion have different wall thickness.
 17. The device ofclaim 1, wherein the second occluding member includes an insert having aheavier weight that the remainder of the second occluding member. 18.The device of claim 1, wherein at least one of the first or secondoccluding members have a bulbous shape.
 19. The device of claim 1,further comprising a lumen extending axially through the first occludingmember, the tether, and the second occluding member.
 20. The device ofclaim 1, wherein the device includes a compound elutable from the deviceinto the gastro-intestinal tract.
 21. The device of claim 20, whereinthe compound is contained in a reservoir disposed in the secondoccluding member.
 22. The device of claim 20, wherein the compound isdisposed on an outer surface of the device.
 23. The device of claim 20,wherein the therapeutic compound is insulin.
 24. The device of claim 1,further comprising a locking mechanism coupled to occluding member andconfigured to maintain the first occluding member in its contractedconfiguration.
 25. The device of claim 24, further comprising a sensorconfigured to confirm and/or detect the contracted configuration of thefirst occluding member.
 26. The device of claim 25, wherein the sensoris configured to detect the contracted configuration via a modalityselected from the group consisting of acoustic, ultrasonic, electrical,electromagnetic, optical (for instance, detecting changes in color,wavelength, frequency, etc.), chemical, and tension.
 27. A method oftreating a disease, the method comprising: disposing a device in apatient's stomach, the device comprising, a proximal member including afirst occluding member and an apron member, and a distal memberincluding a second occluding member connected to the proximal memberwith a tether, wherein the apron member has a proximal open endsurrounding the first occluding member and a distal closed end connectedto the tether, and wherein movements of the stomach cause the device tointermittently obstruct a gastric opening by causing the apron member tobecome intermittently disposed against the gastric opening.
 28. Themethod of claim 27, wherein the disease is one or more of obesity,hyperphagia, or dyslipidemia.
 29. The method of claim 27, wherein thedisease is one or more of Prader Willi syndrome, Froelich's syndrome,Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome,Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, andIV.
 30. The method of claim 27, wherein the device is disposed in thepatient's stomach by introducing the device in the patient's stomach inan elongated, narrower configuration, and by forming the first occludingmember from the elongated, narrower configuration to a contracted, widerconfiguration.
 31. The method of claim 27, further comprising the stepof dispersing a compound from the device into the patient'sgastro-intestinal tract.
 32. The method of claim 31, wherein dispersingthe compound comprises dispersing the compound from a reservoircontained in the device.
 33. The method of claim 32, wherein dispersingthe compound comprises dispersing the compound from a reservoircontained in the distal member.
 34. The method of claim 31, wherein thecompound is disposed on an outer surface of the device.
 35. The methodof claim 31, wherein the compound is insulin.
 36. The method of claim27, further comprising reconfiguring the first occluding member into acontracted, wider configuration within the apron member.
 37. The methodof claim 36, further comprising locking the first occluding member intoits contracted configuration such that passage through the gastricopening is inhibited by the first occluding member.
 38. The method ofclaim 37, further comprising confirming the contracted configuration ofthe first occluding member by visual confirmation.
 39. The method ofclaim 37, further comprising confirming the contracted configuration ofthe first occluding member by a sensor configured to detect thecontracted configuration via a modality selected from the groupconsisting of acoustic, ultrasonic, electrical, electromagnetic, optical(for instance, detecting changes in color, wavelength, frequency, etc.),chemical, and tension.
 40. A method of treating diabetes, the methodcomprising: disposing a device in a patient's stomach, the devicecomprising, a proximal member including a first occluding member and anapron member, and a distal member including a second occluding memberconnected to the proximal member with a tether, wherein the apron memberhas a proximal open end surrounding the first occluding member and adistal closed end connected to the tether, and wherein movements of thestomach cause the device to intermittently obstruct a gastric opening bycausing the apron member to become intermittently disposed against thegastric opening; and dispersing insulin from the device into thepatient's gastro-intestinal tract.
 41. The method of claim 40, furthercomprising the step of managing glucose peaks by configuring theproximal member to slow gastric emptying to predetermined ratios. 42.The method of claim 40, wherein dispersing the insulin comprisesdispersing the insulin from a reservoir included in the device.
 43. Themethod of claim 40, wherein dispersing the insulin comprises dispersingthe insulin from a reservoir included in the distal member.
 44. Themethod of claim 40, wherein dispersing the insulin from the devicecomprises eluting the insulin from a surface of the device.
 45. Themethod of claim 40, wherein dispersing the insulin comprises dispersingthe insulin passively.
 46. The method of claim 40, wherein dispersingthe insulin comprises dispersing the insulin by actuating an insulindispersing system.
 47. The method of claim 46, wherein the insulindispersing system is a pump.
 48. The method of claim 46, wherein theinsulin dispersing system is actuated in response to detection by thedevice of a predetermined condition.
 49. The method of claim 48, whereinthe predetermined condition comprises one or more of a carbohydratelevel, a fat level, and a sugar level.
 50. The method of claim 48,further providing the step of providing a feedback signal to the patientor to a clinician.
 51. The method of claim 50, wherein the feedbacksignal provides a feedback on one or more of the predetermined conditionand of an amount of dispersed insulin.
 52. A combination method oftreating obesity, the method comprising: disposing a device in apatient's stomach, the device comprising, a proximal member including afirst occluding member and an apron member, and a distal memberincluding a second occluding member connected to the proximal memberwith a tether, wherein the apron member has a proximal open endsurrounding the first occluding member and a distal closed end connectedto the tether, and wherein movements of the stomach cause the device tointermittently obstruct a gastric opening by causing the apron member tobecome intermittently disposed against the gastric opening; anddispersing insulin from the device into the patient's gastro-intestinaltract.
 53. The method of claim 52, further comprising the step ofmanaging patient weight by configuring the proximal member to slowgastric emptying to predetermined ratios.
 54. The method of claim 52,wherein dispersing the insulin comprises dispersing the insulin from areservoir included in the device.
 55. The method of claim 52, whereindispersing the insulin comprises dispersing the insulin from a reservoirincluded in the distal member.
 56. The method of claim 52, whereindispersing the insulin comprises dispersing the insulin passively toreduce appetite of the patient.
 57. The method of claim 52, whereindispersing the insulin comprises dispersing the insulin by actuating aninsulin dispersing system.
 58. The method of claim 57, wherein theinsulin dispersing system is a pump.
 59. The method of claim 57, whereinthe insulin dispersing system is time-actuated.
 60. The method of claim57, wherein the insulin dispersing system is actuated in response todetection by the device of a predetermined condition.
 61. The method ofclaim 60, wherein the predetermined condition comprises one or more of acarbohydrate level, a fat level, and a sugar level.
 62. The method ofclaim 60, further providing the step of providing a feedback signal tothe patient or to a clinician.
 63. The method of claim 62, wherein thefeedback signal provides a feedback on one or more of the predeterminedcondition and of an amount of dispersed insulin.